Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight.

INTRODUCTION

Lifestyle modification, such as healthy diet habits, regular physical activity, and maintaining a normal body weight, must be prescribed to all hypertensive individuals. This study aims to test whether a multicomponent intervention is effective in improving lifestyle and body weight among low-income families.

STUDY DESIGN

Cluster randomized trial conducted between June 2013 and October 2016.

SETTING/PARTICIPANTS: A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina.

INTERVENTION

Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages were sent for 18 months.

MAIN OUTCOME MEASURES

Changes in the proportion of behavioral risk factors and body weight from baseline to end of follow-up. Data were analyzed in 2017.

RESULTS

Low fruit and vegetable consumption (fewer than 5 servings per day) decreased from 96.4% at baseline to 92.6% at 18 months in the intervention group, whereas in the control group it increased from 97.0% to 99.9% (p=0.0110). The proportion of low physical activity (<600 MET-minutes/week) decreased from 54.3% at baseline to 46.2% at 18 months in the intervention group and kept constant around 52% (p=0.0232) in the control group. The intervention had no effect on alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000).

CONCLUSIONS

The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina.

TRIAL REGISTRATION

This study is registered at www.clinicaltrials.gov NCT01834131.